Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
  • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
  • A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member

Definitions

• Balloon dilatation catheters are used to treat lesions in ves sels, such as by way of angioplasty. While successful for use in a variety of applications or locations in the vasculature, some situations call for a different approach in view of the possibility of“elastic recoil,” which re fers to the inherent resistance of a tissue to changes in shape, and the ten dency of the tissue to revert to its original shape once deformed. Further more, some applications, and particularly those“below the knee” (BTK) involve hard calcifications, for which balloon angioplasty alone may be contraindicated. Moreover, the use of pharmacological agents to lesions for enhanced treatment may be desirable in some instances, and efficacy may be increased by actively cutting prior to application.
• the apparatus further includes a sheath for receiving the cutter.
• the at least two expandable arms may form a Y-shape at a distal end of the single shaft.
• the first expandable arm includes a pair of blades and may include at least one blade or no blades.
• the first expandable arm may include a limiter for limiting a cut ting depth of the cutter.
• Figure 1 illustrates one embodiment of a cutter according to the disclosure
• Figure 1 includes a distal or head 16a having a blade 20, which includes a thin, blade edge 20a of various shapes (flat, convex, chiseled, single bevel, double bevel, etc.) to provide a precision cut.
• the blade edge 20a may also be serrated (single or double), scalloped, chamfered, wavy, or take other shapes or forms, depending on the particular use, and more than one blade edge may be provided (such as on both a distal and a proximal side of the head 16a, or also on lateral sides thereof).
• the radial expansion of the distal portion or tip 14 may be achieved by forming at least the arms 16, 18 from a material that changes shape based on a change in ambient conditions, such as a shape memory material (e.g. Nitinol) that assumes a particular configuration based on a change in temperature (which may be achieved by supplying fluid via sheath S or based on body temperature).
• a shape memory material e.g. Nitinol
• the degree of expansion may thus be precisely con trolled to ensure that the cutter 10 and, in particular, the blade edge 20a may function to slice or score a lesion in a vessel having a typical diameter, and without expanding the vessel to avoid elastic recoil.
• the cutter 10 may simply be withdrawn into the sheath S and the arms 16, 18 collapsed as a result.
• the sheath S may then be withdrawn or repositioned, as desired.
• the diameter of a vessel may be var iable to a certain degree.
• the cutter 10 and, specifically the arm 16 including the blade edge 20a may optionally be provided with a limiter 22.
• the limiter 22 comprises an oversized portion just proximal of the head 16a of the corresponding arm 16, and may be smooth or rounded so as to not provide a cutting function when contacted with material in the vessel, such as a lesion, calcification, or the like.
• the location of the lim iter 22 may be selected to achieve a desired cutting depth, depending on the particular application.
• the limiter 22 may take other forms, such as a generally spherical bead 24 as shown in Figure 3, which also shows that the second arm 18 includes a blade 20 at a head end thereof.
• the cutter 10 may include an anchor.
• the anchor comprises an ex pandable (inflatable) balloon 32, which may be attached to the shaft 12 proximally of the point of diversion to form the arms 16, 18 (or more if present).
• Inflation fluid for the balloon 32 may be provided via a lumen in the shaft 12 to an outlet O within the interior compartment of the balloon 32.
• the balloon 32 may thus be moved through the sheath S in a collapsed or folded configuration, and then expanded within the vessel to provide a positioning function for the associated cutter 10 once expanded.
• the bal loon 32 may be compliant, non-compliant, or semi-compliant.
• the expandable balloon 32 may also be provided on the sheath S, which may also include an inflation lu men (not shown).
• Figures 10 and 11 further illustrate that, instead of an inflatable balloon 32, the anchor may comprise a self-expanding cage 34. This cage 34 may be provided either on the cutter 10 ( Figure 10) or on the sheath S ( Figure 11).
• Figures 12, 13, 14, and 15 illustrate alternate embodiments.
• An apparatus for slicing or scoring a lesion in a vessel comprising:
• a cutter configured to project from the sheath in a deployed posi tion for slicing or scoring the lesion, the cutter including a single shaft connected to a plurality of expandable arms, including a first expandable arm having at least one blade for scoring or slicing the lesion when the cutter is in the deployed position.
• a cutter including a single shaft having a branched portion including at least two expandable arms, a first of the expandable arms in cluding at least one blade for slicing or scoring the lesion when expanded.
• An apparatus for slicing or scoring a lesion in a vessel comprising:
• phrases“consisting essentially of’ means that the stated entity or item (sys tem, system unit, system sub-unit device, assembly, sub-assembly, mech anism, structure, component element or, peripheral equipment utility, ac cessory, or material, method or process, step or procedure, sub-step or sub procedure), which is an entirety or part of an exemplary embodiment of the disclosed invention, or/and which is used for implementing an exem plary embodiment of the disclosed invention, may include at least one ad ditional feature or characteristic” being a system unit system sub-unit de vice, assembly, sub-assembly, mechanism, structure, component or ele ment or, peripheral equipment utility, accessory, or material, step or pro cedure, sub-step or sub -procedure), but only if each such additional feature or characteristic” does not materially alter the basic novel and inventive characteristics or special technical features, of the claimed item.

Landscapes

• Health & Medical Sciences (AREA)
• Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)

Applications Claiming Priority (1)

Publications (1)

Family

ID=66102178

Family Applications (1)

Country Status (5)

Families Citing this family (1)

Family Cites Families (6)

• 2019
  • 2019-02-28 JP JP2021550154A patent/JP7337182B2/ja active Active
  • 2019-02-28 CN CN201980093164.4A patent/CN113490461A/zh active Pending
  • 2019-02-28 EP EP19716601.0A patent/EP3930602A1/en active Pending
  • 2019-02-28 WO PCT/US2019/019937 patent/WO2020176090A1/en unknown
  • 2019-02-28 US US17/433,676 patent/US20220039827A1/en active Pending
• 2023
  • 2023-04-28 JP JP2023074106A patent/JP2023093719A/ja active Pending

Also Published As

Similar Documents

Legal Events